ArticleThe journal of allergy and clinical immunology. Global2026
The AIM4 Next Step study: Comparing inhaled corticosteroid dose escalation to dupilumab in patients with uncontrolled asthma and type 2 inflammation.
Article in The journal of allergy and clinical immunology. Global, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06572228 (AIM4), which is not on this map. Not yet cited in PubMed.
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AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma
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16 authors.
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Abstract
Background: The Global Initiative for Asthma recommends patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS) plus long-acting β Objective: The AIM4: Next Step study will evaluate whether earlier intervention with dupilumab provides clinical benefit compared to escalation to high-dose ICS/LABA. Methods: AIM4: Next Step (NCT06572228) is a randomized, double-blind, active-controlled study enrolling approximately 250 adolescents and adults with type 2 inflammatory asthma uncontrolled with medium-dose ICS/LABA treatment. Patients will be randomized 1:1 to receive dupilumab 300 mg every 2 weeks plus medium-dose ICS/LABA or placebo plus high-dose ICS/LABA. Results: The primary end point is the annualized rate of severe asthma exacerbations over 52 weeks. Key secondary end points include change from baseline in prebronchodilator forced expiratory volume in 1 second at week 12, annualized systemic corticosteroid exposure for exacerbations, and asthma control at week 12 based on 5-item Asthma Control Questionnaire. Conclusion: AIM4: Next Step is the first study designed to address an important gap in asthma management by directly comparing ICS dose escalation versus early biologic intervention with dupilumab in patients with uncontrolled type 2 inflammatory asthma. Findings may inform future treatment strategies for patients whose asthma remains uncontrolled despite ICS/LABA.
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